Amendment_0001_(SF30)_to_18-223-SOL-1199437.docx

DOCX document 27 KB Posted Jun 14, 2018

Attached to: Advanced Evaporator System (x2) Federal contract opportunity
Solicitation number: FDA-18-223-SOL-1199437
Issued by: Department of Health and Human Services Food and Drug Administration

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The purpose of this Amendment is to post Questions and Answers

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Sol_Doc_(18-223-SOL-1199437).docx	DOCX document	Jun 6, 2018

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18-223-SOL-119437

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
1. CONTRACT ID CODE
PAGE	OF	PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

4. REQUISITION/PURCHASE REQ. NO.

5. PROJECT NO. (If applicable)

0001

06/14/2018

6. ISSUED BY

CODE

7. ADMINISTERED BY (If other than Item 6)

CODE

FDA/OO/OFBA/OAGS/DAP

SUZANNE MARTELLA

3900 NCTR ROAD

BUILDING 50, RM 430, HFT-320

JEFFERSON AR 72079

Same as Block 6

8. NAME AND ADDRESS OF CONTRACTOR (No. Street, county, State and ZIP: Code)

(X)

9A. AMENDMENT OF SOLICITATION NO.

ALL OFFERORS

18-223-SOL-1199437

|X|

9B. DATED (SEE ITEM 11)

06/06/2018

|_|

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE

FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

|X| The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers |_| is extended, |X| is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning one (1) copy of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATA SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and data specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS, IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CHECK ONE
A.	THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

\|_\|
B.	THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

\|_\|
C.	THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

\|_\|
D.	OTHER Specify type of modification and authority)

E. IMPORTANT: Contractor |_| is not, |X| is required to sign this document and return __1_ copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of this Amendment is to post the responses to questions that have been asked regarding the solicitation.

SEE THE FOLLOWING SF30 CONTINUATION PAGES

Except at provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Nick Sartain, Contracting Officer

15B. CONTRACTOR/OFFEROR

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

16C. DATE SIGNED

(Signature of person authorized to sign)

BY _____________________________________________

(Signature of Contracting Officer)

NSN 7540-01-152-8070	STANDARD FORM 30 (REV. 10-83)
PREVIOUS EDITION UNUSABLE	Prescribed by GSA

FDA-SOL-1153590

FAR (48 CFR) 53.243

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

QUESTIONS AND ANSWERS

The following are the questions submitted prior to receipt of proposals and their corresponding answers.

Question 1:	Do they want to concentrate to a specific level with the automatic cutoff? Ex. 1ml, 0.9ml or .5ml or other?
Answer 1:	We would like to have a freedom of changing the volume. There are several steps in our process that requires multiple end volumes, for example 0.5 mL down to 2.0 uL. We are hoping the system would give us this choice to change the end volume.

Question 2:	What is desired evaporation time for 200ml sample to 1ml and specific solvent to consider?
Answer 2:		At present, solvents used are methylene chloride, hexane and toluene. With toluene being the slowest, we are shooting for 30 minutes to go to dryness. The faster, the better. In some portions of our process we have to exchange solvents and would have to stop the system and back on several times.

Question 3:	Will one source for a specific GC vial for the EV tubes be sufficient for the cause?
Answer 3:	At present practice, our final volume inside the cone shape insert located inside the GC vial is 2.0 uL (microliters). The cone shape insert has a plastic spring under it that prevents the GC autoinjector needle from bending or “Z-YING”. We may consider other cone shape GC vials. I would say yes one source for a specific GC vial is used in all our instruments.

(End of Q&A)

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